Quickly: What three technologies impact your drug development and manufacturing? How do those technologies impact your outsourcing partners, processes, and decisions? Thanks for joining today’s flash mind exercise. You’ve also joined executives on the Outsourced Pharma Editorial Advisory Board who did the same. Let’s compare.
When the U.S. Supreme Court granted certiorari in the Sandoz v. Amgen litigation earlier this year, many were hoping for a decision that would clarify some key issues pertaining to the requirements of the BPCIA. But the decision left a number of questions unanswered.
Microbial control is critical in cleanroom environments. Contaminated environments can lead to product recalls, regulatory observations, fines, or even consumer deaths. In order to properly prevent, destroy, and monitor microbial contamination in cleanrooms, several aspects of cleanroom microbiology must be understood. This four-part article provides a foundational introduction to some of those aspects.
It seems blockchain technology is following the hype path the cloud did a few years ago. The most talked-about example of blockchain is Bitcoin, a digital currency that does not rely on a central authority (such as the Federal Reserve) to clear financial transactions. A few short months ago, the word “blockchain” was seldom mentioned in supply chain circles. Now, it’s not uncommon to be asked what your blockchain strategy is within those same circles. What has changed is its successful use and blockchain platforms adding functionality.
The complexity of today’s molecules and the growing majority of new molecule development are calling for a new method of drug production. Biopharma companies of all sizes are looking to vendors to manage development, manufacturing, and capacity needs. The question is: Are they keeping up?
The biomanufacturing industry is undergoing a major shift, from single-product processes and stainless steel infrastructure to flexible, multi-product facilities using singleuse technology.
Here we describe a process development methodology that enables design of either a batch or a continuous chromatography step based on the same set of experimental data.
If your organization has yet to adopt the use of eCOA (electronic clinical outcome assessments) in your clinical trials, then this white paper on successfully implementing the use of this technology should be of interest to you.
Almac has developed a flexible paediatric dosage form consisting of minitablets filled into stickpacks using a robust manufacturing and filling process suitable for routine commercial manufacture.
Manufacturing of biopharmaceuticals is a large commitment to the public health and helps save the lives of millions of people. The complex nature of biopharmaceuticals makes manufacturing a challenge, in which a consistent, high-quality end product is dependent of the use of equally consistent, high-quality key manufacturing components.
Good column packing is essential for any chromatographic process and plays a key role in the large-scale commercial manufacture of biopharmaceuticals. A bed packed too densely may crack, which can lead to channeling and early breakthrough. A bed packed too loosely can further compress, causing a liquid gap where mixing can occur. Either instance will lead to costly process disruptions and loss of valuable product. Proper packing eliminates such concerns and ensures a stable bed that performs according to expectations over many processing cycles.
Manufacturing of biological and small molecule drug products is on the rise, and more often than not, generation of stability data and getting product released for clinical trials are on the critical path to approval. Emergent Camden not only understands that, but delivers quality product in timelines significantly shorter than other contract manufacturers.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
Choosing a supplier with a strong quality and supply track record, as well as broad technology platform and deep bioprocessing expertise, will simplify the entire process. To be a credible partner, they need to be able to provide technical and regulatory insight, understand your processing needs, be experienced in facility design, and provide advanced operator training and the right level of support to bring your capacity online faster.
In the broadest sense, the purpose of a quality agreement is to clearly define, establish and delineate the responsibilities of the respective QA departments from the service provider and its customer, in order to clearly communicate the responsibilities of each party, with the ultimate goal of assuring patient safety and regulatory compliance. An added benefit of implementing a clear, concise quality agreement is that it creates a more effective and efficient working relationship between service provider and customer.
Despite this tremendous growth, drugmakers still face a number of challenges in the manufacturing process for ADCs. Here are key areas where pharma manufacturers face the biggest uphill battles.
Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.
This white paper explores best practices in SaaS selection and incorporation into laboratory practices that enable organizations to focus on their core competencies while utilizing best-of-breed software.